DIEGO SUCTION-IRRIGATION TUBING SET, DISPOSABLE 12'(3.66 m) LENGTH N

GUDID 00821925026223

Gyrus Acmi, Inc.

ENT shaver system

• Primary Device ID: 00821925026223
• NIH Device Record Key: cb3b0852-f896-44c8-8d21-b6a2364fa6e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO SUCTION-IRRIGATION TUBING SET, DISPOSABLE 12'(3.66 m) LENGTH N
• Version Model Number: 70338003
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925026223 [Package]; Contains: 00821925034006; Package: [6 Units]; In Commercial Distribution
GS1	00821925034006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020594

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-12